Label: BACLOFEN tablet
- NDC Code(s): 80425-0466-1, 80425-0466-2, 80425-0466-3, 80425-0466-4
- Packager: Advanced Rx of Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 59651-395
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 29, 2024
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- Official Label (Printer Friendly)
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DESCRIPTIONBaclofen USP, is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural ...
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Clinical PharmacologyThe precise mechanism of action of baclofen is not fully known. Baclofen is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of ...
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Indications and UsageBaclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus ...
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CONTRAINDICATIONSHypersensitivity to baclofen.
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WARNINGSa. Neonatal Withdrawal Symptoms:Withdrawal symptoms have been reported starting hours to days after delivery in neonates whose mothers were treated with oral baclofen throughout pregnancy ...
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PRECAUTIONSBecause of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness ...
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ADVERSE REACTIONSThe most common is transient drowsiness (10% to 63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the ...
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OVERDOSAGESigns and Symptoms:Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression, and seizures. Treatment:In the alert patient, empty the stomach promptly ...
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DOSAGE AND ADMINISTRATIONThe determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40 to 80 mg daily). The ...
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HOW SUPPLIEDBaclofen Tablets USP, 20 mg are white to off-white, round, flat-faced, beveled-edge scored tablet debossed with “B” above score line and “20” below score line on one side and plain on other side ...
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg
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INGREDIENTS AND APPEARANCEProduct Information